Clinical Research Center of the Carolinas | Charleston, SC
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The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).
Full description
The study will be conducted as randomized, double blind and vehicle-controlled ( 4:1 ratio of verum (BF-200 ALA; Ameluz®) to vehicle (placebo)) clinical trial at 15 sites in the United States of America (US). Each site should randomize between 10 and 20 subjects.
Each subject will complete a clinical observation period that will last for up to 7 months (up to 4 weeks screening and pre-randomization period, and up to 6 months clinical observation period) followed by a 5-year follow-up (FU) period after the completion of the first PDT cycle.
The treatment of superficial BCC lesion(s) comprises of up to two PDT cycles each with two PDT sessions one to two weeks apart of each other. 12 weeks after the first PDT of the first cycle lesion(s) will be assessed clinically and only subjects with remaining BCC lesion(s) will be retreated in the second PDT cycle starting the same day. For clinically completely cleared subjects the clinical observation period of the study will end and these subjects will enter the FU part of the study.
For each subject a Main Target Lesion will be defined that will be excised either 12 weeks after the first PDT of the first cycle, if clinically cleared, or at the end of the clinical observation period in order to histologically confirm the clinical assessment. Additional Target Lesions will be assessed clinically, only. Randomization will be stratified by the number of lesions (1 vs ≥2 Lesion(s)).
Definitions of complete responders comprise of:
Verum and vehicle are indistinguishable. However, treatment is accompanied with typical adverse events (AEs). In order to guarantee the blind status of the investigator assessing efficacy after each PDT cycle, a second investigator or delegated person will perform drug application and light treatment as well as all safety evaluations at visits where PDT is applied and during the phone call 1 week after each PDT cycle, respectively. Both investigators (delegated person(s)) are not entitled to exchange information about the study outcome and side effects.
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Inclusion criteria
Exclusion criteria
History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA which includes soybean phosphatidylcholine.
Hypersensitivity to porphyrins.
Current treatment with immunosuppression therapy.
Presence of photodermatoses.
Presence of porphyria.
Presence of clinically significant inherited or acquired coagulation defect.
Evidence of clinically significant (CS) unstable medical conditions, such as:
Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic diseases that complicate implementation of the protocol or interpretation of the study results.
Gorlin Syndrome or Xeroderma pigmentosum.
Presence and/or physical treatment of skin tumors other than (naïve) sBCC (e.g. malignant melanoma, squamous cell carcinoma (SCC), Bowen's disease, aggressive BCC or nBCC diagnosed at the screening visit by clinical assessment) within a distance of ≤ 5 cm from the nearest target lesion within 4 weeks prior to PDT (Visit 2) until the end of the clinical observation period. However, biopsied lesion(s) that were not confirmed eligible at screening and which are located at a distance of > 5 cm from any lesion(s) that will be included in the study can be surgically removed. Treatment by PDT or topical medication during the course of the clinical observation period of the study triggers exclusion of the subject.
If lesion(s) are assessed as non-eligible by biopsy during initial screening and these lesions are localized within a distance of 5 cm from an otherwise suitable lesion, this suitable lesion must be excluded from the study.
Αny AK lesions within the treatment field (lesion area including margin of 0.5 to 1.0 cm).
Any topical medical treatment of AK, other non-melanoma skin cancers (NMSC), or melanoma (except for IMP treatment of the target lesion(s)) starting 12 weeks prior to Visit 2 (PDT-1) and lasting until the end of the clinical observation period.
Any other topical medical treatment of the skin 12 weeks prior to Visit 2 (PDT-1) until the end of the clinical observation period, with the exception of:
Start of intake of medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening.
Any of the systemic treatments listed below, within the designated period prior to PDT and during the clinical observation period.
Systemic treatment with NSAIDs is not to be used 7 days prior to and 7 days after PDT. ASA (e.g. Aspirin®) up to 100 mg/ day, ibuprofen up to 200 mg/ day, and acetaminophen (e.g. Tylenol®) is allowed during this period.
Presence of tattoos, skin inflammation, wounds, etc. in the treatment field(s) plus a 5 cm radius surrounding the target lesion(s).
Primary purpose
Allocation
Interventional model
Masking
186 participants in 2 patient groups, including a placebo group
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Central trial contact
Matthias Lübbert
Data sourced from clinicaltrials.gov
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